Choroidal Melanoma Clinical Trial
Official title:
An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma
Verified date | April 2012 |
Source | The New York Eye Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a Phase I clinical trial to test the safety and tolerability of intravitreal
ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for
patients with choroidal melanoma using the incidence and severity of events criteria.
The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression
of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein
angiography, and optical coherence tomography, as well as visual acuity.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of radiation retinopathy - History of choroidal melanoma status post plaque brachytherapy - Age > 21 years - Ability to perform written consent and comply with study assessments for the full duration of the study Exclusion Criteria: - Pregnancy or lactation, pre-menopausal women not using contraception - Participation in another simultaneous medical investigation or trial - Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. - Patients who have undergone intraocular surgery within last 60 days. - Patients who have had intravitreal anti-VEGF treatment within 45 days. - Patients who have had intravitreal triamcinolone acetonide within 4 months. - Patients who have had laser within 60 days. - Inability to obtain photographs to document CNV (including difficulty with venous access). - Patient has a history of any medical condition which would preclude scheduled visits or completion of study. - Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless as a result of yttrium aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens implantation.. - History of glaucoma filtering surgery in the study eye. - Concurrent use of more than two therapies for glaucoma. - Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The New York Eye Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
The New York Eye Cancer Center | Genentech, Inc. |
United States,
Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6. — View Citation
Finger PT, Chin KJ. Intravitreous ranibizumab (lucentis) for radiation maculopathy. Arch Ophthalmol. 2010 Feb;128(2):249-52. doi: 10.1001/archophthalmol.2009.376. — View Citation
Finger PT. Radiation retinopathy is treatable with anti-vascular endothelial growth factor bevacizumab (Avastin). Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):974-7. doi: 10.1016/j.ijrobp.2007.11.045. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy associated with plaque brachytherapy for choroidal melanoma | 12 months | Yes | |
Secondary | To assess the efficacy of intravitreal ranibizumab on treating radiation retinopathy following plaque brachytherapy for choroidal melanoma, and effect on visual acuity | 12 months | No |
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